Comparative Clinical Study of Intraocular Lens Injectors Lioli™, Pioli™, and Pioli™ Plus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cataract, Lens Implantation, Intraocular. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this observational study is to evaluate whether different intraocular lens (IOL) injectors affect surgical outcomes in patients aged 40 and older undergoing cataract surgery. The main questions it aims to answer are: * Do different IOL injectors change the size of the corneal incision during surgery? * Do the injectors lead to different rates of complications during or after surgery? Researchers will compare the use of three different IOL injectors: two preloaded models (pioli™ and pioli™ Plus) and one manually loaded model (lioli™), to see if the preloaded systems improve surgical results compared to the manual one. Participants will: * Undergo routine cataract surgery using one of the three injectors, randomly assigned. * Have measurements taken before and after surgery (e.g., vision tests, corneal incision size). * Be monitored for any side effects or complications during and after the procedure.
Primary outcome measures
- Change in Corneal Incision Size [Time frame: Day of surgery (intraoperative)]
- Incidence of Adverse Events [Time frame: From surgical incision to end of surgery, assessed up to 120 minutes (intraoperative), and From end of surgery until postoperative day 30 (postoperative)]
Secondary outcome measures (1)
- Procedure Duration [Time frame: During surgery]
Eligibility criteria
Inclusion criteria
- Age 40 years or older
- Scheduled for cataract surgery using phacoemulsification technique
- Planned implantation of an Asqelio™ monofocal intraocular lens (IOL)
- Clear intraocular media, except for the presence of cataract (i.e., no other significant ocular opacities)
Exclusion criteria
- Preoperative corneal astigmatism > 1.0 diopter (D)
- Previous corneal surgery or history of ocular trauma
- Irregular cornea (e.g., keratoconus)
- Choroidal hemorrhage
- Microphthalmos
- Severe corneal dystrophy
- Uncontrolled or medically controlled glaucoma
- Clinically significant macular changes
- Severe concomitant ocular disease
- Cataract not related to aging
- Severe optic nerve atrophy
- Diabetic retinopathy
- Proliferative diabetic retinopathy
- Amblyopia
- Extremely shallow anterior chamber
- Severe chronic uveitis
- Pregnant or breastfeeding
- Rubella
- Mature or dense cataracts that prevent preoperative retinal examination
- History of retinal detachment
- Concurrent participation in another drug or medical device clinical study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Clínica OftalVist Sevilla — Seville
Identifiers
NCT: NCT07140029 · PIOLI012022